Paranasal ostium finder devices and methods

ABSTRACT

Devices and methods for locating sinus ostia and positioning a guide wire within the sinus ostia. The subject devices include a shaft having a distal end, a proximal end, a curved region located between the distal and proximal ends, and an interior channel, an extensible and retractable guide wire movably mounted within the interior channel and a probe tip joined to the guide wire. Certain devices further include expandable portions for engaging and treating body anatomy.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application claims the benefit of Provisional Application Ser. No.61/084,965, filed Jul. 30, 2008, the contents of which are incorporatedby reference.

FIELD OF THE INVENTION

The present invention relates generally to medical devices, systems andmethods and more particularly to methods and devices for locating anddilating paranasal sinus ostia.

BACKGROUND OF THE INVENTION

The skull contains a series of cavities known as paranasal sinuses thatare connected by passageways. The paranasal sinuses include frontalsinuses, ethmoid sinuses, sphenoid sinuses and maxillary sinuses. Theparanasal sinuses are lined with mucous-producing mucosal tissue andultimately open into the nasal cavity. Normally, mucous produced by themucosal tissue slowly drains out of each sinus through an opening knownas an ostium. If the mucosal tissue of one of these passageways becomesinflamed for any reason, the cavities which drain through thatpassageway can become blocked. This blockage can be periodic (resultingin episodes of pain) or chronic. This interference with drainage ofmucous (e.g., occlusion of a sinus ostium) can result in mucosalcongestion within the paranasal sinuses. Chronic mucosal congestion ofthe sinuses can cause damage to the epithelium that lines the sinus withsubsequent decreased oxygen tension and microbial growth (e.g., a sinusinfection).

The term “sinusitis” refers generally to any inflammation or infectionof the paranasal sinuses caused by bacteria, viruses, fungi (molds),allergies or combinations thereof. It has been estimated that chronicsinusitis (e.g., lasting more than 3 months or so) results in 18 millionto 22 million physician office visits per year in the United States.Patients who suffer from sinusitis typically experience at least some ofthe following symptoms: headaches or facial pain; nasal congestion orpost-nasal drainage; difficulty breathing through one or both nostrils;bad breath; and/or pain in the upper teeth.

One of the ways to treat sinusitis is by restoring the lost mucous flow.The initial therapy is typically drug therapy using anti-inflammatoryagents to reduce the inflammation and antibiotics to treat theinfection. A large number of patients do not respond to drug therapy.Currently, the gold standard for patients with chronic sinusitis that donot respond to drug therapy is a corrective surgery called FunctionalEndoscopic Sinus Surgery (FESS).

During FESS, an endoscope is inserted into the nose and, undervisualization through the endoscope, the surgeon may remove diseased orhypertrophic tissue or bone and may enlarge the ostia of the sinuses torestore normal drainage of the sinuses. FESS procedures are typicallyperformed with the patient under general anesthesia.

Although FESS continues to be the gold standard therapy for surgicaltreatment of severe sinus disease, FESS does have several shortcomings.For example, FESS can cause significant post-operative pain. Also, someFESS procedures are associated with significant post-operative bleedingand, as a result, nasal packing is frequently placed in the patient'snose for some period of time following the surgery. Such nasal packingcan be uncomfortable and can interfere with normal breathing, eating,drinking etc. Also, some patients remain symptomatic even after multipleFESS surgeries. Additionally, some FESS procedures are associated withrisks of iatrogenic orbital, intracranial and sino-nasal injury. Manyotolaryngologists consider FESS an option only for patients who sufferfrom severe sinus disease (e.g., those showing significant abnormalitiesunder CT scan). Thus, patients with less severe disease may not beconsidered candidates for FESS. One of the reasons why FESS procedurescan be bloody and painful relates to the fact that instruments havingstraight, rigid shafts are used. In order to target deep areas of theanatomy with such straight rigid instrumentation, the physician needs toresect and remove or otherwise manipulate any anatomical structures thatmay lie in the direct path of the instruments, regardless of whetherthose anatomical structures are part of the pathology.

New devices, systems and techniques are being developed for thetreatment of sinusitis and other disorders of the ear, nose, throat andparanasal sinuses. For example, various catheters, guide wires and otherdevices useable to perform minimally invasive, minimally traumatic ear,nose and throat surgery have been described in U.S. patent applicationSer. No. 10/829,917 entitled “Devices, Systems and Methods forDiagnosing and Treating Sinusitis and Other Disorders of the Ears, Noseand/or Throat,” issued as U.S. Pat. No. 7,654,997 on Feb. 2, 2010; Ser.No. 10/912,578 entitled “Implantable Device and Methods for DeliveringDrugs and Other Substances to Treat Sinusitis and Other Disorders,”issued as U.S. Pat. No. 7,361,168 on Apr. 22, 2008; Ser. No. 10/944,270entitled “Apparatus and Methods for Dilating and Modifying Ostia ofParanasal Sinuses and Other Intranasal or Paranasal Structures,”published as U.S. Pat. Pub. No. 2006/0004323 on Jan. 5, 2006, nowabandoned; Ser. No. 11/037,548 entitled “Devices, Systems and MethodsFor Treating Disorders of the Ear, Nose and Throat”, issued as U.S. Pat.No. 7,462,175 on Dec. 9, 2008; and Ser. No. 11/116,118 entitled “Methodsand Devices For Performing Procedures Within the Ear, Nose, Throat andParanasal Sinuses,” issued as U.S. Pat. No. 7,720,521 on May 18, 2010.Each of these applications is hereby incorporated herein, in itsentirety, by reference thereto. Many of these new devices, systems andtechniques are useable in conjunction with endoscopic, radiographicand/or electronic/electromagnetic visualization assistance to facilitateprecise positioning and movement of catheters, guide wires and otherdevices within the ear, nose, throat and paranasal sinuses and to avoidundesirable trauma or damage to critical anatomical structures such asthe eyes, facial nerves and brain.

In one new procedure (referred to herein as a “Flexible Transnasal SinusIntervention” or FTSI, or the Balloon Sinuplasty™ procedure), adilatation catheter (e.g., a balloon catheter or other type of dilator)is advanced through the nose or some other entry path into the patient'shead to a position within the ostium of a paranasal sinus or otherlocation, without requiring removal or surgical alteration of otherintranasal anatomical structures. The dilatation catheter is then usedto dilate the ostium or other anatomical structures (such as man-madeopenings into a paranasal sinus and/or spaces within the nasal cavity)to facilitate natural drainage from the sinus cavity. In some cases, atubular guide may be initially inserted through the nose and advanced toa position near the sinus ostium, and a guide wire may then be advancedthrough the tubular guide and into the affected paranasal sinus. Thedilatation catheter may then be advanced over the guide wire and throughthe tubular guide to a position where its dilator (e.g., balloon) ispositioned within the sinus ostium. The dilator (e.g., balloon) is thenexpanded, causing the ostium to dilate. In some cases, such dilatationof the ostium may fracture, move or remodel bony structures thatsurround or are adjacent to the ostium. Optionally, in some procedures,irrigation solution and/or therapeutic agents may be infused through alumen of the dilatation catheter and/or other working devices (e.g.,guide wires, catheters, cannula, tubes, dilators, balloons, substanceinjectors, needles, penetrators, cutters, debriders, microdebriders,hemostatic devices, cautery devices, cryosurgical devices, heaters,coolers, scopes, endoscopes, light guides, phototherapy devices, drills,rasps, saws, etc.) may be advanced through the tubular guide and/or overthe guide wire to deliver other therapy to the sinus or adjacent tissuesduring the same procedure in which the FTSI is carried out. In FTSIprocedures, structures and passageways other than sinus ostia may bedilated using the tools described above, tissue may be resected orablated, bone may be restructured, drugs or drug delivery systems may bedeployed, etc., as described in the documents incorporated herein byreference.

In FTSI procedures that include positioning of a guide wire into aparanasal sinus, the placement of the guide wire through a sinus ostiumis typically preceded by the user finding the target ostium with a sinusseeker. The user or surgeon places a sinus seeker into the nasalpassageway, and then by tactile feedback (i.e., by “feel”) finds thetarget ostium by contacting the distal end of the sinus seeker with thetarget sinus ostium. Use of more than one sinus seeker device may berequired to locate the target ostium. The surgeon then removes the sinusseeker from the patient and introduces a guide catheter into the nasalpassage. The guide wire is introduced into the nasal passageway throughthe guide catheter and, by tactile memory, the surgeon directs orpositions the guide wire to the target ostium. When fluoroscopy or otherx-ray visualization techniques are available, the physician may stillutilize a sinus seeker prior to inserting the guide wire into a patientdue to the physician's familiarity with using a sinus seeker to find thetarget ostium.

The insertion and removal of the ostium locating device, followed byintroduction of a guide catheter and guide wire, results in repeatedintrusion of devices into the patient's paranasal cavity and maycorrespondingly result in increased tissue trauma, increasedpost-operative recovery time, and/or increased surgery time (and thuscost) involved in the procedure. Presently, no single device is capableof both finding a target ostium and introducing a guide wire into theparanasal cavity to the target ostia, thus allowing the completion oftwo tasks in one step. There is a need for such methods and devices thatcan accurately determine the position of a target paranasal sinus ostiumand also feed or position a guide wire into the target ostium duringsinus procedures.

A need also exists for simplified devices and methods for accessing anddilating a maxillary sinus ostium. The maxillary sinus ostium can oftenbe difficult to locate and treat, and in many cases it may beadvantageous to dilate the maxillary ostium and also dilate an area ormove an anatomical structure outside of the sinus (in the paranasalcavity) to help treat sinusitis. For example, it may be desirable insome case to dilate the middle meatus or infundibulum or move the middlemeatus, anterior ethmoid air cell or uncinate process. It would be idealif a physician could do so without removing tissue and with a relativelyconvenient tool or set of tools. The present invention will address atleast some of these needs.

The present disclosure addresses these and other needs.

SUMMARY

The invention provides sinus seeker or sinus ostium finder or seekerdevices and methods for introducing a guide wire into a target sinusostium using the sinus seeker device itself. The present disclosure alsoprovides a probe with a dilator for locating and dilating the maxillarysinus and for dilating a space outside the maxillary sinus.

The sinus ostium finder of the invention comprises, in general terms: ashaft having a distal end, a proximal end, a curved region locatedbetween the distal and proximal ends, and an interior channel; anextensible and retractable guide wire movably mounted within theinterior channel; and a probe tip joined to the guide wire. The guidewire is reversibly movable between a retracted position wherein theprobe tip is adjacent to the distal end, and an extended positionwherein the probe tip is separated from the distal end.

The probe with dilator device includes a shaft with a rigid proximal endand a less rigid, curved distal end with an atraumatic, probe-likedistal tip. The device can further include one or more expandabledilators attached along the shaft such as to the curved distal portionor which is advanceable along the shaft.

In certain embodiments the probe tip is detachable and interchangeable.

In certain embodiments the sinus ostium finder further comprises ahandle joined to the proximal end.

In certain embodiments the shaft further comprises an exterior sheathand an interior element, the interior channel extending through theinterior element.

In certain embodiments the interior element comprises a rigid materialand the exterior sheath comprises a resilient material.

In certain embodiments the interior element is removable andinterchangeable.

In certain embodiments the sinus ostium finder further comprises anactuator element mechanically coupled to the guide wire. The actuatorelement may be located on the handle and mechanically coupled to theguide wire. The actuator element may be slidably mounted within a sloton the handle.

In certain embodiments the shaft further comprises a tubular innersheath and a tubular outer sheath, the inner sheath positioned withinthe outer sheath, the interior channel extending through the innersheath.

In certain embodiments the interior sheath may be extensible andretractable with respect to the outer sheath.

In certain embodiments the shaft further comprises a slot communicatingwith the interior channel, the slot structured and configured to allowthe guide wire to be inserted into and removed from the interior channelthrough the slot.

In certain embodiments the outer sheath includes a first slot and theinner sheath includes a second slot, the first and second slotsstructured and configured to allow the guide wire to be inserted intoand removed from the interior channel through the first and second slotswhen the first and second slots are aligned with each other.

In certain embodiments the shaft further comprises a front portion and aback portion joined to the front portion, the front and back portionsdefining a tubular shape, the interior channel located between the frontand back portions.

In certain embodiments the front portion further comprises a slot, theslot communicating with the interior channel, the slot structured andconfigured to allow the guide wire to be inserted into and removed fromthe interior channel through the slot.

In many embodiments the sinus ostium finder of the invention maycomprise:

an elongated shaft having a distal end and a proximal end, and a curvedregion between the proximal and distal ends; a handle joined to theproximal end; a longitudinal interior channel extending through theshaft and the handle; an extensible and retractable guide wire movablymounted within the interior channel; a probe tip joined to an end of theguide wire; and an actuator element associated with the handle andmechanically coupled to the guide wire, the guide wire extensible andretractable according to adjustment of the actuator element.

The invention also provides methods for locating a target ostium. Thesubject methods comprise, in general terms: providing a sinus ostiumfinder having a shaft with a distal end, a proximal end, a curved regionlocated between the distal and proximal ends, and an interior channel,with an extensible and retractable guide wire movably mounted within theinterior channel, and a probe tip joined to the guide wire; insertingthe shaft of the sinus ostium finder into a patient's paranasal cavity;adjusting the position of the distal end of the shaft; and adjusting theposition of the guide wire and the probe tip until the target ostium islocated.

In certain embodiments the methods further comprise withdrawing theshaft from the paranasal cavity while leaving the guide wire and theprobe tip in the adjusted position.

In certain embodiments the methods further comprise introducing asurgical device along the guide wire to the target ostium.

In certain embodiments, the probe can embody a device for locating anddilating a natural ostium of a maxillary sinus, the device comprising anelongate shaft, comprising a substantially rigid proximal portion, acurved distal portion, an atraumatic distal tip at the end of the curveddistal portion, wherein the curved distal portion has a size and shapeto allow passage of the distal portion into a nasal cavity to positionthe atraumatic distal tip within or near a maxillary sinus ostium and aninflation lumen passing through at least part of the shaft, at least oneexpandable dilator coupled with the distal portion of the shaft in fluidcommunication with the inflation lumen.

In other embodiments, the device for locating and dilating a naturalostium of a maxillary sinus can embody an elongate inner shaft,comprising a substantially rigid proximal portion, a curved distalportion, and an atraumatic distal tip at the end of the curved distalportion, wherein the curved distal portion has a size and shape to allowpassage of the distal portion into a nasal cavity to position theatraumatic distal tip within or near a maxillary sinus ostium and anouter shaft slidably disposed over the inner shaft and including aninflation lumen, and at least one expandable dilator coupled with thedistal portion of the shaft in fluid communication with the inflationlumen.

In a related method, locating and dilating a maxillary sinus ostium caninvolve a maxillary sinus, the method comprising advancing a curveddistal portion of a maxillary sinus device into a nasal cavity, whereina proximal portion of the maxillary sinus device is substantially rigid,passing an atraumatic distal end of the distal portion through thenatural ostium of the maxillary sinus, using tactile feedback to confirmpassage of the distal end through the ostium and dilating at least oneexpandable dilator coupled with the curved distal portion of themaxillary sinus device to dilate the natural maxillary sinus ostium.

Additionally, in certain embodiments, the distal tip of the device canlight up to provide transillumination.

In certain embodiments, the device can be coupled or used with avariable degree of view endoscope for viewing the maxillary ostium.

These and other advantages and features of the invention will becomeapparent to those persons skilled in the art upon reading the details ofthe devices, methods and systems as more fully described below.

BRIEF DESCRIPTION OF THE DRAWING

FIG. 1 is an illustration of a patient being treated by a prior artsystem for catheter-based sinus surgery according to prior arttechniques.

FIG. 2 a is a side elevation view of a sinus ostium finder in accordancewith the invention shown with a guide wire in a retracted position.

FIG. 2 b is a side elevation view of the sinus ostium finder of FIG. 3 ashown with a guide wire in an extended position.

FIGS. 3 a and 3 b are fluoroscopic images (A-P orientation) showing thesinus ostium finder of FIGS. 2 a and 2 b locating the left maxillarysinus ostium and deploying a guide wire.

FIG. 4 a through Fig. c are fluoroscopic images (A-P orientation)showing another embodiment of a sinus ostium finder locating the leftfrontal sinus ostium and deploying a guide wire.

FIG. 5 a is a perspective view of another embodiment of a sinus ostiumfinder in accordance with the invention shown with a guide wire in aretracted position.

FIG. 5 b is a perspective view of the sinus ostium finder of FIG. 4 ashown with the guide wire in an extended position.

FIG. 5 c is a cross-section of the sinus ostium finder of FIGS. 4 a and4 b taken through line A-A.

FIG. 6 is a perspective view of another embodiment of a sinus ostiumfinder in accordance with the invention.

FIG. 7 is a perspective view of the distal end portion of anotherembodiment of a sinus ostium finder in accordance with the invention.

FIG. 8 a is a perspective view of another embodiment of a sinus ostiumfinder in accordance with the invention shown with a guide wire in apartially detached position.

FIG. 8 b is a perspective view of a distal end portion of anotherembodiment of a sinus ostium finder in accordance with the invention.

FIG. 9 is a partial perspective view of another embodiment of the sinusostium finder of the invention.

FIG. 10 a is a front elevation view of a distal end portion of anotherembodiment of the invention, shown without the guide wire.

FIG. 10 b is a longitudinal sectional view taken through line B-B of thedistal end portion of FIG. 10 a shown with a guide wire positionedwithin the internal longitudinal channel.

FIG. 10 c shows the distal end portion of FIG. 10 b with the guide wirepartially removed from the internal longitudinal channel.

FIG. 11 a is a perspective view of the distal end portion of anotherembodiment of a sinus ostium seeker in accordance with the inventionshown without a guide wire.

FIG. 11 b is a cross-sectional view of the distal end portion of FIG. 11a taken through line C-C.

FIG. 12 a is a cross-sectional view of a distal end portion of anotherembodiment of a sinus seeker apparatus in accordance with the inventionshown without a guide wire.

FIG. 12 b shows the distal end portion of FIG. 12 b with a guide wire.

FIG. 12 c shows the distal end portion of FIG. 12 b including alubricant.

FIG. 13 is a flow chart illustrating one embodiment of the methods ofthe invention.

FIG. 14 is a cross-sectional view of anatomy proximate a maxillarysinus.

FIG. 15 is a cross-sectional view depicting use of a guide, guide wireand balloon catheter for treating a maxillary sinus.

FIG. 16 is a side view of one embodiment of a probe device with adilator.

FIGS. 17 a-d are cross-sectional views depicting treating a maxillarysinus with the device of FIG. 16.

FIGS. 18 a-c are partial cross-sectional views depicting use of a probeover a shaped mandrel.

FIGS. 19 a-b are perspective views of another approach to a probe devicewith a dilator.

FIG. 20 is a side view of yet another embodiment of a probe device.

FIG. 21 is a perspective view of another approach to a probe device.

FIG. 22 is a perspective view of yet another approach to a probe device.

FIG. 23 is a partial cross-sectional view depicting another embodimentof a probe device.

FIG. 24 is a partial cross-sectional view depicting another alternateembodiment of a probe device.

FIG. 25 is a perspective view depicting a probe device including detailsof a handle assembly.

FIG. 26 is a partial cross-sectional view depicting a probe with afinder tip.

FIG. 27 is a perspective view of a handle for a probe device.

FIGS. 28 a-c depict steps involved in a method of use of the device ofFIG. 26.

DETAILED DESCRIPTION

This invention is not limited to particular embodiments described, assuch may, of course, vary. It is also to be understood that theterminology used herein is for the purpose of describing particularembodiments only, and is not intended to be limiting, since the scope ofthe present invention will be limited only by the appended claims.

Where a range of values is provided, it should be understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimits of that range is also specifically disclosed. Each smaller rangebetween any stated value or intervening value in a stated range and anyother stated or intervening value in that stated range is encompassedwithin the invention. The upper and lower limits of these smaller rangesmay independently be included or excluded in the range, and each rangewhere either, neither or both limits are included in the smaller rangesis also encompassed within the invention, subject to any specificallyexcluded limit in the stated range. Where the stated range includes oneor both of the limits, ranges excluding either or both of those includedlimits are also included in the invention.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. Although any methods andmaterials similar or equivalent to those described herein can be used inthe practice or testing of the present invention, the preferred methodsand materials are now described. All publications mentioned herein areincorporated herein by reference to disclose and describe the methodsand/or materials in connection with which the publications are cited.

It must be noted that as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include plural referents unless thecontext clearly dictates otherwise. Thus, for example, reference to “atube” includes a plurality of such tubes and reference to “the shaft”includes reference to one or more shafts and equivalents thereof knownto those skilled in the art, and so forth.

The publications discussed herein are provided solely for theirdisclosure prior to the filing date of the present application. Nothingherein is to be construed as an admission that the present invention isnot entitled to antedate such publication by virtue of prior invention.Further, the dates of publication provided may be different from theactual publication dates which may need to be independently confirmed.

Turning now to FIG. 1, an illustration of a patient being treated by asystem for catheter-based minimally invasive sinus surgery according toprior art techniques is shown. A C-arm fluoroscope 1000 that is useableto visualize a guide catheter 1002, a guide wire 1002, and a workingdevice 1006 (e.g., a balloon catheter, other dilatation catheter,debrider, cutter, etc.). The guide tube 1002 may be introduced underdirect visualization, visualization provided by fluoroscope 1000 and/orfrom endoscopic visualization, to place the distal end of tube 1002 at alocation associated with an ostium of a sinus to be treated. Guide wire1004 is then inserted through tube 1002 and advanced to extend thedistal end of guide wire 1004 to the ostium to be treated. Properplacement often involves advancement and retraction of the distal end ofguide wire 1004 until it has been visually confirmed that the guide wireis properly positioned. Working device 1006 is next passed over theguide wire 1004 to the target location where a surgical procedure is tobe performed. After performance of the surgical procedure, the workingdevice 1006 is deactivated and withdrawn from the patient, after whichthe guide wire 1004 and guide catheter 1002 are withdrawn to completethe procedure.

Referring now to FIGS. 2 a and 2 b, a sinus ostium seeker, finder orlocator device 10 in accordance with the invention is shown. The sinusfinder 10 of the invention comprises a shaft or body 11 having aproximal end 12, a distal end 14, and a curved portion or region 16.Shaft 11 and curved portion 16 define an elongated tubular shape andsupport a guide wire 18 (FIG. 2 b) within an internal channel or cavity(not shown) that extends through shaft 11 and curved region 16 to distalend 14. Curved region 16 may be adjacent to distal end 14 or separatedfrom distal end 14 by a straight or uncurved portion of shaft or body11. Guide wire 18 is extensible and retractable from shaft 11 throughthe distal end 14. A probe tip 20 on guide wire 18 is configured forlocating a target ostium. Guide wire 18 is shown in a retracted positionin FIG. 2 a wherein probe tip 20 is adjacent or proximate to distal end14, and in an extended position in FIG. 2 b wherein probe tip 20 ispositioned away from distal end 14. Proximal end 12 may be joined to ahandle (not shown). The extension and retraction of guide wire 18 may becontrolled by application of suitable force to guide wire 18.

Shaft 11 and curved portion 16 are shown as integral portions of asingle piece or unit in the embodiment of FIGS. 2 a and 2 b. In certainembodiments the shaft 11 and curved portion 16 may comprise separatecomponents that are joined together. The curved portion 16 as showndefines an angle of approximately 90 degrees or slightly greater thanninety degrees. This angle may vary as required for different uses ofthe invention. Preferably, curved portion defines an angle of betweenabout 0 degrees and about 180 degrees, and more preferably between about0 degrees and about 120 degrees, and providing several iterations at 0degrees, 30 degrees, 70 degrees, 90 degrees and 110 degrees, or asrequired to accommodate a particular sinus surgery operation.

Curved portion 16 may be detachable from the remainder of shaft 11 andinterchangeable to allow variation of curvature. Curved portion 16and/or body 11 in many embodiments are resilient to facilitatepositioning within a patient's paranasal cavity. In certain embodimentscurved portion 16 and shaft 11 are malleable or bendable. In still otherembodiments curved portion 16 is resilient or malleable, and shaft 11 issubstantially rigid in nature.

Probe tip 20 is structured and configured to facilitate location of atarget ostium. In many embodiments probe tip 20 is spherical or oblongin shape, but may be varied in shape as required for different uses ofthe invention. Probe tip 20 and distal end 14 are structured andconfigured to provide atraumatic surfaces to minimize trauma or damageto the patient's paranasal cavity. Probe tip 20 may be detachable fromguide wire 18 and interchangeable, so that different sized and/or shapedprobe tips 20 may be utilized for location of different sinus ostia.

Guide wire 18 may be extended or retracted manually by hand actuated,electric, or air-driven mechanism (not shown), such as a slide,rotatable crank, winch device, reel assembly, or the like. In certainembodiments the extension and retraction of guide wire 18 may beachieved by an electric or air-driven motor (not shown) that ismechanically interfaced with guide wire 18. Guide wire 18 is resilientor flexible in many embodiments to allow the user to easily locate probetip 20 to a desired location. In certain embodiments guide wire 18 maybe bendable or malleable rather than resilient.

Shaft 11, curved portion 16, probe tip 20, guide wire 18, as well ascomponents of the invention in the several embodiments described herein,may be made of various metals or metal alloys, or polymeric materialssuch as engineering resins, or composite materials thereof, or variouscombinations of such materials. Preferably biocompatible materials, orcoatings of biocompatible materials, are utilized for shaft 11, curvedportion 16, probe tip 20 and guide wire 18 to minimize trauma toparanasal cavity tissue that comes in contact with sinus seeker 10.Shaft 11 and curved portion 16 in many embodiments are integral portionsof a single component. Shaft 11 and/or curved portion 16 may bemalleable, as noted above, such that the angle of curved portion 16 isadjustable by bending to accommodate a particular use. Shaft 11, curvedportion 16, probe tip 20 and guide wire 18 and other components of theinvention in many embodiments are made of materials that areautoclavable or otherwise sterilizable so that the apparatus 10 orindividual components may be re-used. In certain embodiments the shaft11, curved portion 16, probe tip 20 and guide wire 18 may be made ofinexpensive, disposable materials.

In FIGS. 3 a and 3 b, the sinus ostium finder 10 is shownfluoroscopically in use to locate the left maxillary sinus ostium O1.The body or shaft 11 of sinus ostium finder is positioned within thepatient's paranasal cavity P, and guide wire 18 (FIG. 3 b) is extendedfrom body 11 to locate ostium O1. Guide wire 18 is resilient ormalleable as noted above, and may undergo flexing or bending over asubstantial range of angle. As shown in FIG. 3 b, the portion of guidewire 18 adjacent probe tip 20 is approximately parallel with the portionof guide wire 18 adjacent to distal end 14, indicating a flexion angleof approximately 180 degrees in guide wire 18 between distal end 14 andprobe tip 20. Once the guide wire 18 has been positioned into themaxillary sinus cavity O1, shaft 11 and curved portion 16 may be removedor withdrawn from the patient's paranasal cavity P while leaving behindthe guide wire 18, thus allowing other working devices (not shown) to beintroduced over the guide wire 18 and then into the target sinus. Incertain embodiments, the sinus ostium finder 10 may include radio-opaquemarkings (not shown) on shaft 11, curved portion 16, probe tip 20 and/orguide wire 18 to facilitate fluoroscopic visualization of the finder 10and help in the navigation of finder 11 within the patient's nasalpassageway P. The radio-opaque markings may comprise, for example,gradation markings to show dimensions or distances and numerical indiciaidentifying the gradation markings.

Referring now to FIGS. 4 a through 4 c, there is shown anotherembodiment sinus ostium finder 21 in accordance with the invention, withlike reference numbers used to denote like parts. The sinus ostiumfinder 21 is shown fluoroscopically in use to locate the left frontalsinus ostium O2 of a patient. In the embodiment of FIGS. 4 a through 4c, the curved region 16 of sinus ostium finder 21 defines an angle ofapproximately 150 degrees of curvature. The sinus ostium finder 10 ofFIGS. 3 a and 3 b, in comparison, has a curved region 16 that defines anangle of approximately 110 degrees. In other respects the sinus ostiumfinder 21 is identical to sinus ostium finder 10.

In FIG. 4 a, sinus ostium finder 21 is shown inserted into paranasalcavity P, with guide wire (not shown) in a fully retracted position suchthat probe tip 20 is positioned adjacent distal end 14. In FIG. 4 b,guide wire 18 is shown partly extended from distal end 14. In FIG. 4 c,guide wire is more fully extended such that probe tip 20 at the end ofguide wire 18 is able to locate ostium O2.

FIGS. 5 a, 5 b and 5 c show yet another embodiment of sinus seeker orfinder 22 in accordance with the invention, wherein like referencenumbers are used to represent like parts. The sinus seeker 22 includes ahandle portion 24 having distal and proximal end portions 26, 28respectively (with only part of the proximal end portion 28 beingshown). In the embodiment of FIGS. 5 a-5 c, handle 24 is of elongatedcylindrical configuration and is structured to allow a user to manuallyadjust the position of shaft 11 and curved portion 16 within a paranasalcavity. Handle 24 is joined to the proximal end 12 of body or shaft 11at joint 30 by means of internal threading (not shown), snap fitting orother suitable attachment means, and may be detachable from shaft 11 andinterchangeable. Alternatively, handle 24 may be made integral withshaft 11. Curved portion 16 is joined to body or shaft 11 at joint 32 byinternal threading (not shown), snap fitting or other suitableattachment means, and may be detachable from shaft 11 as noted above.Alternatively, curved portion 16 may be integral with shaft 11.

An interior opening or channel 34 extends longitudinally through handle24, shaft 11 and curved portion 16, with channel 34 being configured toslidably or movably accommodate guide wire 18. In general, the innerdiameter of the longitudinal channel 34 ranges from about 0.5 mm toabout 5 mm, and more preferably from about 1 mm to about 3 mm, dependingon the size of guide wire 18 utilized with the invention.

Referring more particularly to FIG. 5 c, the curved portion 16 of sinusseeker 22 may further comprise a flexible or resilient outer sheath 36and an internal element 38 within sheath 36. In the embodiment of FIG. 5c, outer sheath 36 is of circular cross-sectional shape, while internalelement 38 is of a “U” or “C” cross-sectional shape such thatlongitudinal channel 34 and guide wire 18 are located between portionsor ends 40, 42. Internal element 38 may be removable from sheath 36 andinterchangeable. Internal element 38 may be of higher modulus materialthan sheath 36, such that the curvilinear shape and flexural propertiesof internal element 38 are imparted to curved portion 16. The materialof internal portion 38 may be selected for desired flexural or malleableproperties. In many embodiments internal element may also extend throughshaft 11, or through shaft 11 and handle. In certain embodiments theouter sheath 36 may comprise a higher modulus material than internalelement 38 such that the shape and flexural properties of the curvedregion are derived from sheath 36 rather than internal element 38. Inmany embodiments internal element 38 may also extend through shaft 11,or through shaft 11 and handle 24.

Referring now to FIG. 6, another embodiment of a sinus ostium finder orseeker 44 in accordance with the invention is shown, with like referencenumbers used to denote like parts. The handle 24 of sinus seeker 44 isof elongated cylindrical shape and includes a longitudinal slot 46 thatcommunicates with interior channel 34. A knob or actuator element 48 isslidably mounted within slot 46. Knob 48 is mechanically coupled toguide wire 18 such that movement of knob towards distal end 26 of handle24 advances guide wire 18 and probe tip 20 from distal end 14, as shownin FIG. 6, when actuator 48 is positioned adjacent to distal end of slot46. Sliding of actuator 48 to the proximal end of slot 46 results in acorresponding retraction of guide wire 18 and probe tip 20, asillustrated in phantom lines.

Referring next to FIG. 7, there is shown a portion of another embodimentof a sinus ostium finder 50 in accordance with the invention. Sinusseeker 50 includes an outer sheath 52 of substantially tubular shape,and an inner sheath 54 positioned within outer sheath 52. Inner sheath54 is also of substantially tubular shape. A longitudinal channel 34extends through inner sheath 54 and is structured and configured toslidably accommodate guide wire 18. In the embodiment of FIG. 7,longitudinal channel 34 is of substantially circular cross-sectionalshape.

Outer sheath 52 may extend along a portion of, or the entire length ofshaft 11, including the curved region (not shown). Inner sheath 54 maylikewise extend along a portion of, or the entire length of, the curvedportion and shaft. Inner sheath 54 may be slidably extensible andretractable with respect to outer sheath 52, such that during extensionthe distal end 56 of inner sheath 54 moves away from distal end 58 ofouter sheath, and during retraction the distal end 56 of inner sheath 54approaches distal end 58 of outer sheath 52. The extension andretraction of inner sheath 54 with respect to outer sheath 52 may becontrolled by an actuator knob such as knob 48 in FIG. 6

Inner sheath 54 may be of higher modulus material than outer sheath 52,such that the shape and mechanical properties of inner sheath areimparted to curved portion and/or shaft (not shown) of the sinus seeker50. In other embodiments the outer sheath 52 may comprise higher modulusmaterial than that of the inner sheath. The material of inner sheath 52and/or outer sheath may be selected for specific flexural or malleableproperties in accordance with the desired use of the invention.

FIG. 8 a shows yet another embodiment of a sinus seeker 60, wherein likereference numbers denote like parts. The distal end 14 of sinus seeker60 includes a longitudinal slot 62 that communicates with the internallongitudinal channel 34. Slot 62 may extend along the length of all orportion of curved region 16 and shaft 11. Actuation of knob 48 in themanner described above allows guide wire 18 to be advanced or retractedwith respect to distal end 14. FIG. 8 a shows knob 48 positionedadjacent to proximal end 28 of handle 24, corresponding to a retractedposition for guide wire 18.

Slot 62 allows guide wire 18 to be removed from channel 34 through slot62, as well as by extension from distal end 14. Curvilinear portion 16in this regard may be made of resilient material such that guide wire 18is retained within channel 34 under normal conditions, but can “snap”out of slot 62 to disengage from channel 34 upon application of alateral force to guide wire 18. As shown in FIG. 8 a, guide wire 18 ispartially disengaged from channel 34 and slot 62. Disengagement of guidewire 18 through slot 62 as provided by sinus seeker 60 facilitatesremoval and interchanging of guide wire 18 and probe tip 20, andfacilitates removal of shaft 11, curved portion 16 and distal end 14from a target sinus or adjacent regions of the paranasal cavity whileleaving guide wire 18 and probe tip 20 in place. A working device (notshown) may then be directed along guide wire 18 to the target sinus tocarry out surgical procedures.

In the embodiment of FIG. 8 a, shaft 11 is extensible and retractablewith respect to handle 24. A sleeve or collar 64 supports shaft 11 andmay be tensioned by means of a screw or threaded parts (not shown) tosecure shaft in place. Loosening of collar 64 allows shaft 11 to beextended or retracted from collar 64 and handle 24 to provide adifferent length and configuration to sinus seeker 60. Once shaft 11 hasbeen adjusted to a desired length by extension or retraction from handle24, collar 64 may be tensioned to retain the adjusted position of shaft11.

FIG. 8 b shows a distal portion of another embodiment of a sinus ostiumfinder 68 in accordance with the invention. The apparatus 68 includes anouter sheath 70 of substantially cylindrical or tubular shape, and aninner sheath 72 substantially cylindrical or tubular shape positionedwithin outer sheath 70. A longitudinal channel 34 extends through innersheath 72 and is structured and configured to slidably accommodate guidewire 18. In the embodiment of FIG. 8 b, longitudinal channel 34 is ofsubstantially circular cross-sectional shape.

A longitudinal slot 74 extends through inner sheath 72 and communicateswith longitudinal channel 34. Slot 74 permits guide wire 18 to beremoved from channel 34 in a lateral direction upon exertion of alateral force on guide wire 18. Outer sheath 70 may also include alongitudinal slot 76, which extends through outer sheath 72 tocommunicate with longitudinal slot 74 and hence longitudinal channel 34.Thus, guide wire 18 may be removed laterally from inner and outersheaths 72, 70 via slots 74, 72 upon application of a suitable lateralforce on guide wire 18.

In the embodiment of FIG. 8 b longitudinal slots 74, 76 are aligned sothat both slots 74, 76 communicate with internal channel 34 to allowinsertion and release of guide wire 18 from channel. In certainembodiments one or both of the inner sheath 72 and outer sheath 70 maybe rotatable with respect to each other along the longitudinal axis A ofthe shaft and curved region (not shown) of the apparatus 68. Innersheath 72, outer sheath 70, or both may be mechanically coupled to arotational adjustment mechanism on the handle (not shown of theapparatus 68, so that the rotational position of sheath 70 and/or sheath72 may be rotatably adjusted to control alignment of slots 74, 76. Thus,when one of sheaths 70, 72 is rotated with respect to the other, slots74, 76 may be moved out of alignment so that guide wire 18 cannot beremoved through slots 74, 76, or aligned as shown in FIG. 8 b so thatguide wire 18 can be removed from channel 34 through slots 74, 76.

Outer sheath 70 may extend along a portion of, or the entire length of,the curved portion and shaft (not shown in FIG. 8 b) of the sinus seekerapparatus 68. Inner sheath 72 may similarly extend along a portion of,or the entire length of, the curved portion and shaft. Inner sheath 72may be slidably extensible and retractable with respect to outer sheath70, with distal end 78 of inner sheath 72 moving away from distal end 80of outer sheath 70 during extension, and with distal end 78 movingtowards distal end 80 during extension.

FIG. 9 illustrates still another embodiment of a sinus ostium seeker 82in accordance with the invention, wherein like reference numbers denotelike parts. The apparatus 82 includes a longitudinal slot 84 thatextends from distal end 14 to the distal end 26 of handle 24.Longitudinal slot 84 communicates with longitudinal channel 34, whichextends through handle 24, shaft 11 and curved region 16 to distal end14. Slot 84 includes a laterally curving region 86 such that the end 88of slot 84 adjacent handle distal end 26 has a different angularorientation (relative to a central axis passing through the shaft 11)than the end 90 of slot 84 adjacent distal end 14 with respect to shaft11 and curved region 16, such that slot 84 “twists” relative to shaft 11as it traverses from its distal end to its proximal end. Thus, in FIG.9, the portion of slot 84 adjacent slot end 88 is rotated from theportion of slot 84 adjacent end 90 with respect to the longitudinal axis(not shown) defined by shaft 11 and curved portion 16. The laterallycurving region 86 of slot 84 facilitates the insertion and removal ofguide wire 18 into or out of interior longitudinal channel 34.

Referring now to FIG. 10 a through 10 c, a distal portion of anotherembodiment of a sinus ostium finder 92 in accordance with the inventionis shown, with like numbers used to denote like parts. The apparatus 92includes an opening 94 that extends longitudinally from distal end 14across curved portion 16 to shaft 11. Opening 94 communicates withinternal longitudinal channel 34. Opening 94 is structured andconfigured to allow a user to grasp guide wire 18 through opening 94,using fingers, forceps or other grasping tool (not shown). Opening 94facilitates the removal of guide wire 18 from the channel 34 and theapparatus 92. In this way, the proximal end (not shown) of the guidewire can be loaded into the distal end 14 of the shaft 11 where thecutout 94 in the bend helps pass a stiff proximal end of the guidewireinto the body of the guide catheter despite the sharp bend angle of thecurved tip. Thus, the guidewire can take a less severe bend duringloading. Once loaded, the system is configured as shown in FIG. 10B.After the system is used to place the tip of the guide wire into thesinus, the guide catheter can be pulled back off the proximal end of theguide wire.

FIGS. 11 a and 11 b show a distal portion of another embodiment of asinus ostium finder 96 in accordance with the invention, with likereference numbers used to denote like parts. The apparatus 96 includesan elongated back portion 98 and an elongated front portion 100 that arejoined together along seams 102, 104 by adhesive, heat welding or otherbonding means. Back and front portions 98, 100 together define a tubularshape, with an interior channel 34 of circular cross-sectional shapebetween the front and back portions 98, 100. Front and back portions 98,100 extend from distal end 14 along curved region 16 and shaft (notshown), and together define the curved region 16 and shaft (not shown)of the apparatus 96. A longitudinal slot 106 in front portion 100communicates with interior channel 34. In the embodiment of FIGS. 11 aand 11 b, front and back portions 100, 98 each are semicircular incross-sectional shape and impart a circular cross-sectional shape tointerior channel 34.

In many embodiments back portion 98 is made of a rigid or substantiallyrigid higher modulus material, while front portion 100 comprises aresilient lower modulus material. The resilient nature of front portion100 allows a guide wire (not shown) to “snap fit” through slot 106between ends 108, 110 (FIG. 11 b). The guide wire thus can be easilyinserted into and removed from channel 34 by application of a suitableforce against front portion 100 to force or move the guide wire throughslot 106. In certain embodiments both front and back portions maycomprise flexible materials.

FIGS. 12 a through 12 c provide cross-sectional views of a portion ofyet another sinus ostium finder 112 in accordance with the invention,with like numbers used to denote like parts. The apparatus 112 includesan outer sheath 114 and an inner section or portion 116 positionedwithin sheath 114. Sheath 114 is of elongated tubular configuration anddefines an interior channel 34 that extends longitudinally through thecurved region and shaft (not shown) of the apparatus 112. Inner section116 fits within channel 34 and extends along all or a portion of theshaft and curved region. A slot 118 extends longitudinally along sheath114 and communicates with interior channel 34. In the embodiment shownin FIGS. 12 a through 12 c, sheath 114 is of circular cross-sectionalshape and inner section 116 is of arcuate or semicircularcross-sectional shape such that the cross-sectional shape of innersection 116 conforms to the cross-sectional shape of sheath 114. A guidewire 18 (FIGS. 12 b and 12 c) fits within channel 34.

Sheath 114 is made of resilient material such that guide wire 18 can beforced between ends or portions 120, 122 through slot 188 and intochannel 34. Guide wire 18 then is retained within channel 34 until asuitable force is applied to wire to bring wire through slot 118 betweenends 120, 122 and out of channel 34. Inner section 116 in manyembodiments is made of a rigid or substantially rigid material, or amaterial of higher modulus than that of sheath 114.

A coating 124 (FIG. 12 c) of biocompatible low friction coefficientmaterial such as TEFLON™ may be included on guide wire 18 to facilitatesliding motion of guide wire 18 within channel 34 and to reduce orminimize possible trauma to a patient's paranasal cavity. A lubricatingoil or gel 126 (FIG. 12 c) may be included within channel 34 tofacilitate movement of guide wire 34 within channel 34.

The methods of the invention will be more fully understood by referenceto the flow chart of FIG. 13, as well as FIGS. 2-12. The sequence of theevents described below may vary and should not be considered limiting.Not all events described may occur in a particular use of the invention,and in certain embodiments additional events not shown in FIG. 13 may becarried out.

In event 200, the shaft 11 of the sinus ostium finder of the inventionis inserted into a patient's paranasal cavity. As shown in FIGS. 3 and4, this event is carried out by inserting distal end 14, followed bycurved region 16 and shaft 11 into paranasal cavity P. The insertion maybe carried out by a surgeon or other medical personnel, and may bemonitored fluoroscopically and/or endoscopically, or may be carried outwithout visualization tools.

In event 210, the position of distal end 14 is adjusted. In manyembodiments the adjustment is carried out manually, positioning distalend 14 by suitable manual positioning of handle 24. The positioning ofdistal end 14 in many embodiments is monitored fluoroscopically, so thatthe distal end 14, as well as shaft 11 and curved region 14 may bevisualized. It is to be recognized that alternatively, such positioningcan be visualized solely by endoscopic visualization. The adjustment ofthe position of distal end 14 is carried out with the goal of locating atarget sinus ostium in the event(s) below. In certain embodimentsradio-opaque markings or markings provided by visually contrastingcolors may be included on distal end 14, shaft 11 and/or curved region16 to assist in locating the target ostium.

In event 220, the position of guide wire 18 and probe tip 11 is adjustedby extension of guide wire 18 from distal end 14 until probe tip 20approaches or reaches the target ostium. The positioning of guide wire18 and probe tip 20 is generally monitored fluoroscopically, so that theposition of probe tip 20 with respect to the target ostium may bevisualized. In certain embodiments radio-opaque and radio-transparentmarkings may be included on probe tip 20 and/or guide wire 20 to assistin locating the target ostium.

In event 230, a determination is made whether or not the target ostiumhas been located. The determination is made by visually such asendoscopically, fluoroscopically or using light-emittingtransillumination to observe the location or position of probe tip 20with respect to the target ostium. In many embodiments the probe tip 20is selected to have a diameter that matches that of the target ostium,and location of the target ostium is determined by exactly fitting theprobe tip 20 into the target ostium. If the target ostium has beenlocated, event 240 is carried out.

If it is determined in event 230 that the target ostium has not beenlocated, event 220 may be repeated by again adjusting the position ofguide wire 18 and probe tip 20. This may be carried out by retractingguide wire 18 towards distal end 14, and then re-extending guide wire 18from distal end 14 to adjust the position of guide wire 18 and probe tip20 and direct probe tip 20 towards the target ostium.

In certain instances where it is determined in event 230 that the targetostium has not been located, both events 210 and 220 are repeated. Thus,guide wire 18 is retracted, the position or orientation of distal end 14is adjusted by manually positioning the sinus ostium finder apparatus,and then guide wire 18 is again advanced to adjust the position of guidewire 18 and probe tip 20.

In still further instances where it is determined in event 230 that thetarget ostium has not been located, events 200 through 220 may berepeated. In such instances guide wire 18 would be retracted, and thesinus ostium finder withdrawn from the paranasal cavity. Then, adifferent, more suitably configured sinus ostium finder would bere-inserted into the paranasal cavity and events 210 through 230 arerepeated. Alternatively, the probe tip 20 may be removed from guide wireand a differently sized or shaped probe tip 20 may be introduced toguide wire, after which events 210 through 230 are repeated.

At event 240, shaft 11 (including curved region 16 and distal end 14) isremoved from the paranasal cavity while leaving guide wire 18 and probetip 20 in place in their adjusted position. In embodiments of theinvention wherein the shaft 11 includes a slot, guide wire 18 may bedisengaged from the slot prior to removal of the shaft 11.

In event 250, a surgical or working device or devices are introducedalong the guide wire 18 and directed along the guide wire 18 to thetarget ostium. Such devices may comprise, for example, catheters,cannula, tubes, dilators, balloons, substance injectors, needles,penetrators, cutters, debriders, microdebriders, hemostatic devices,cautery devices, cryosurgical devices, heaters, coolers, scopes,endoscopes, light guides, phototherapy devices, drills, rasps, saws, andthe like.

In event 260 a surgical or other procedure is carried out using theworking device introduced in event 250.

In event 270, the working device and guide wire are withdrawn from theparanasal cavity.

Referring now to FIGS. 14 and 15, in a related approach, variousembodiments may provide for dilating and/or remodeling a sinus ostiumand/or a transitional space leading to an ostia. In particular, thedevices, systems and methods described below are directed to remodelinga maxillary sinus ostium and/or a transitional space leading to amaxillary ostium. In alternative embodiments, ostia and/or transitionalspaces of other paranasal sinuses may be dilated. Dilating orremodelling a transitional space may mean dilating a general anatomicalarea in the vicinity of an ostium and/or moving one or more anatomicalstructures in that general anatomical area. Such dilation or remodellingmay in some cases facilitate or enhance flow of air, mucus and/or othersubstances into and/or out of a maxillary sinus.

With reference to FIG. 14, the nasal/paranasal cavity outside themaxillary sinus has a transitional space formed by and including theanatomical structures and spaces called the infundibulum I, the uncinateprocess U, the ethmoid bulla B, the middle turbinate MT and the middlemeatus. In various embodiments, any of these structures may be movedand/or any of these areas may be dilated.

Referring now to FIG. 15, the anatomy of the maxillary sinustransitional space, like that of the paranasal cavity and the sinusesthemselves, consists of bone and mucosa. Flexible and rigid instrumentsmay be conceived to remove obstruction in the transitional space. Asshown in FIG. 15, one flexible embodiment may involve a balloon catheter300. The area may be accessed using a guide 302 and guidewire 304 andthe balloon catheter 300 may be positioned in the transitional space andinflated. However, this approach requires the coordinated use of severaldevices. The approach may further require multiple guides 302 toposition the balloon 300 appropriately.

Referring now to FIG. 16, a simplified probe device 310 can include amalleable or semi-rigid region 312 extending from a handle 314. Theprobe tip 316 can be curved and is contemplated to embody a dilator 318such as a balloon. A proximal end of the handle 314 is equipped with aluer 320 for accepting an inflation device operable to expand thedilator 318. In this configuration, the curve of the probe tip 316 maybe adjusted to optimize access behind the uncinate and in thetransitional space leading to the maxillary sinus. When an inflationdevice (not shown) is attached the balloon can be inflated, creatingspace in the transitional area as well as dilating the maxillary sinusostium. This device may be used as a single hand instrument under directvision, fluoroscopy, and/or image guidance. Guides and guidewires may beadapted for use therewith but may not be necessary.

The balloon dilator 318 of the probe device 310 may have variousattributes and configurations. For example, the balloon 318 may benon-compliant, semi-compliant, or compliant. Further there may be one orseveral balloons, and the balloons may be concentric or non-concentric.Moreover, the contemplated balloon 318 may have multiple diameters andlengths, multiple taper geometries, and it may end at or before thedistal tip of the probe, or extend beyond the probe. The balloon 318 mayalso have modified frictional properties to release or gain traction onanatomy, such as a non-slip surface. In various embodiments, the balloon318 may have round or non-round cross-sectional geometries to assistre-wrap and profile.

In one contemplated approach, as shown in FIGS. 17 a-d, the balloon 318may be non-concentric and may be oriented to inflate on the outside ofthe curve 316 of the probe 310. The balloon 318 may relatively long,extending from the medial shaft 320 to beyond the probe tip 316. Wheninflated, the balloon 318 does not push the uncinate U. However, theballoon is configurable to push medially on the middle turbinate MT andposteriorly on the bulla B, thereby opening the transitional space (SeeFIGS. 17 c and d). The balloon 318 may also extend beyond the probe tip316 to ensure that the infundibulum has been remodeled and to exertmedial force on the middle turbinate MT.

In another example, a concentric and relatively short balloon (notshown) may push the uncinate U anteriorly and may have some posteriorimpact on the bulla B. There would not necessarily be an impact on themiddle turbinate MT. In alternative embodiments, the same or similardevices may be used to remove or reduce obstruction in the frontal andsphenoid transitional spaces. When used in conjunction with a viewingdevice, the physician may be able to open the transitional space for themaxillary sinus and visually confirm if the ostium is open or closed. Ifthe ostium is closed, the surgeon may opt to use traditional sinuplastydevices or other methods. If the ostium is open, then removal ofobstructions in the transitional space may be a sufficient treatment.

As shown in FIGS. 18 a-c, another probe device 330 for dilating theinfundibulum, bulla, and/or middle turbinate, as well as the maxillaryostium, is shown. In particular, probe device 330 is configured to firstaccess the maxillary ostium by tactile feel. Next, a member is advancedthrough the maxillary ostium and then employed to dilate the anatomicalstructures in the area. Here, the probe device 300 includes a balloon332 configured with a ball tip 334. The device 330 is further configuredto receive a shaped mandrel 336 within an interior lumen 338.

As shown in FIG. 18 b, the balloon portion 332 is advanced over themandrel 336, the mandrel 336 directing the balloon 332 transversely. Byusing this structure, the balloon 332 passes through the maxillaryostium O. Next, the balloon 332 is dilated, which consequently pushesthe middle turbinate MT medially and the bulla B posteriorly. Thedilation also opens the ostium O and infundibulum, whereas the uncinateis pushed anteriorly. The mandrel 336 enables the probe device 330 totolerate the dilation pressure used to expand the balloon 332 withoutusing a guidewire.

The interior lumen 338 or the probe device 330 is constructed to allowretraction over the mandrel 336 without kinking. The mandrel 336 itselfcould be spring tempered or malleable. The mandrel 336 may also have ashort coil or soft tip to reduce kinking of the inner member duringballoon retraction. The mandrel 336 may further be constructed of ashape memory alloy which would conform to the balloon 336 geometry wheninflated. This may also help in reducing stress on the interior lumen338 and kinking during balloon retraction.

In an alternative embodiment, the probe device 320 may be modified toaddress the sphenoid or frontal paranasal sinuses by using asubstantially straight or less severely curved mandrel, respectively. Insome embodiments, an optional sheath (not shown) may be integrated ontoa shaft of the probe to help re-wrap the balloon and thus reduce theoverall profile of the balloon after dilation and deflation.

In some embodiments, the probe device 320 facilitates the use of tactilefeel and balloon advancement to confirm ostial access. This is generallydesirable when using the device in the maxillary and sphenoid sinusesand/or their transitional areas, but it may not work as well in thefrontal sinus. Several additional means of confirmation may also beadapted. For example, a fluid may be flushed through a lumen of theprobe device 336. If the fluid is seen endoscopically in the nasalcavity, it can be assumed that the device has not entered the sinus.Alternatively, light fibers may be added to the tip of the device totransilluminate a sinus. This addition of light fibers andtransillumination may be used in the maxillary, sphenoid or frontalsinus.

In another embodiment, an image guidance sensor may be fixed to the tipof the probe device 320 and tracked with an electro-magnetic system.This would provide confirmation for each of the sinuses. Fluoroscopycould also be used to confirm access. Likewise, a flexible fiber scopecould be passed down the center of the probe device 320 to visualize thearea if the tip of the device 320 has entered the target sinus.

Turning now to FIGS. 19 a and b, an alternative approach to a probedevice 350 is shown. The device 350 includes a rigid or malleable shaftmember 352 that terminates with an uncinate hook 354. A balloon 356 isconfigured about the hook 354 to provide a supported shape intended tomaintain an access turn about an uncinate. Upon dilation, the balloon356 forms a C-like shape, and anatomy at the interventional site ismoved. For example, when placed into the sinuses, a terminal end 358 ofthe device 350 opens an infundibulum, an area 360 proximal the end 358opens a supra-balloon space, a middle section 362 opens the middlemeatus and a most proximal portion 364 of the balloon moves the middleturbinate. Thus, the device 350 can greatly and uniformly open themeatus and infundibulum to make easier the subsequent access the to thefrontal, maxillary or ethmoid sinuses.

In a related device 370, and with reference now to FIG. 20, a balloonportion 372 is eccentrically located on a hook portion 374. The hookportion 374 can be either rigid or malleable. A shaft 376 is configuredproximal to the balloon portion 372, and the device 370 can furtherinclude a tube 376 extending to a terminal end of the device, the tube376 including an exit for a guidewire (not shown).

Yet further approaches to probe devices are depicted in FIGS. 21 and 22.In one embodiment, as shown in FIG. 21, a probe device 380 can embody ashaft 382 with a curved middle meatus/maxillary balloon 384 attachedthereto. The balloon 384 includes a distal portion forming a maxillaryregion 386 and a proximal portion defining a middle meatus region 388.The balloon 384 is configured to have a built-in curve to turn about apatient's uncinate process.

In another embodiment, as shown in FIG. 22, a probe device 390 mayinclude a shaft 396 and a balloon 391 having a maxillary region 392embodying an increased diameter configured distally and about a curvefrom a meatus region 394. In either this or the previous embodiment, themaxillary region 392 and meatus region 394 of the balloon 391 may beformed from different balloon materials, with for example, the maxillaryregion 392 being more compliant. The two regions 392, 394 can furtherembody different shapes such as the maxillary side defining a dog-boneconfiguration. In this way, use of the probe devices 380, 390accomplishes simultaneous dilation of both the maxillary and middlemeatus regions, while protecting the uncinate from trauma. Also, themeatus balloon region 388, 394 of these devices can function to anchorthe maxillary balloon region 386, 392 against sudden movement.

Referring now to FIG. 23, in another embodiment, a-transition spacedilation tool 400 may include a balloon 402 attached about a distalportion of a semi rigid, rigid or malleable shaft 404. A distal end ofthe shaft 404 can be equipped with a ball-like atraumatic tip 406. Theballoon 402 can be mechanically captured by a ball-shaft interface 408to thereby minimize a neck region of the balloon 402. Moreover, theshaft 404 may include an inflatable lumen exit 410 for expanding theballoon 402, which may be pre-shaped into a hook. An inflation hub 411may further be included to provide a dilation means.

The balloon 402 of this probe device 400 generally includes threeregions: an infundibulum balloon region 412; a bullar balloon region414; and a middle meatal balloon region 416. The infundibulum region 412is configured to dilate infundibulum transitional space, the bullarregion 414 compresses bulla to make room for scopes or other devices andthe middle meatal region 416 opens meatal space to reduce potentialtrauma from subsequent device insertion. Each region may have differentdiameters or thicknesses and can define a myriad of shapes, angles andcurves. Further, the shaft 404 can be single or multi-lumened, and theballoon can be compliant, semi-compliant or non-compliant.

With reference now to FIG. 24, an infundibular meatal orrecess-transition space dilator 420 may include a shaft 422 having aball tip 424 and a curved distal portion surrounded by a balloon 426. Aninflation opening 428 is provided in the shaft 422 region surrounded bythe balloon 426 and notably, the ball tip 424 is encapsulated by theballoon 426. The balloon 426 further includes a middle turbinate region430, a bullar region 432 and an infundibular region 434. The balloon canbe molded with a closed end or can be traditionally molded and then thetip molded over and closed. As before, the balloon material can benon-elastic, partially elastic, compliant, non-compliant or partiallycompliant.

In yet another approach, and with reference now to FIG. 25, a probedevice 440 includes a separate internal element 442 that can be advancedand retracted to give tactile feedback to find a maxillary ostium. Oncethe maxillary ostium has been found, the user can independently advancea balloon portion 444 over a hypotube portion 446. The internal element442 can be a wire or some other flexible element which can be extendedout of the shaped hypotube 446 to probe for the sinus. In certainapproaches, the internal element 442 can be coiled wire over a nitinolcore, a solid flexible wire or plastic member, a light wire, or otherflexible element. The shaped hypotube 446 can be formed from a steel orplastic tube that has a curve to direct the internal flexible member 442and external balloon 444. In various embodiments, the tube can bepre-shaped for a specific sinus or malleable to allow the user to shapethe device for a target trajectory.

The balloon 444 is configured about an outside of the shaped hypotube446 and can be advanced independently of the internal element 442. Aballoon shaft 448 is provided with one or two lumens to allowadvancement of the balloon 444 and for inflation. The shaft 448 mayextend over around the hypotube curve 446 or can start proximal thecurve. A balloon pusher 450 is further provided to translate force froma balloon driver 452 to the balloon 444. This structure also may act asa manifold for fluid to fill/pressurize the balloon.

A probe handle 454 can be shaped to form an elongate structure and canbe slender for easy holding and control. The handle 454 can furtherinclude a finger grip for assisting with traction for holding oradvancing elements. The handle 454 also includes an internal elementcontrol 455 which slides within the handle 454 and allows the user tocontrol advancing/retracting the internal element 442 as well asreceiving tactile feedback from the internal element 442. The handlealso includes a balloon driver 456 which slides within the handle 454and allows user to advance/retract balloon. Rails 457 are furtherprovided for guiding the movement of the internal control element 455and push rods (not shown) connecting the balloon driver to the balloonpusher. In various alternative embodiments, balloon inflation fluid maybe passed through one or both of the rails 457, if they are tubes, oralternatively, the probe device 440 may include one or more separateinflation lumens for delivering fluid/pressure to the balloon.

In certain circumstances, when attempting to access a maxillary sinusopening with a probe device including a shaping mandrel, it can beuseful to have a mandrel with a very tight radius to send the probingend of the tip into the right place. It may also be useful to have thestarting tip length itself be relatively short. The tip may need to havea finer selection end on the front. If the balloon catheter lumen itselfis too large, bulky and/or stiff, it can pass by an ostium opening whenadvanced, without entering the opening, because the opening can be morelike a hole in the side of the wall, and not necessarily at the end ofan infundibular pocket. Further, even if the tip does momentarily engagethe ostium, the stiffness of the balloon catheter can overpower it, andit will not enter the opening once the balloon is attempted to beadvanced. Thus, a more flexible lead-in section that supports theballoon stiffness transition into the opening may be employed in someembodiments.

Turning now to FIG. 26, a probe device 460 having a small, short angledtip to select the side-hole ostium when that anatomy is present isdescribed. This device includes a floppy lead-in catheter section thatalso has good column strength that permits advancement forward into anostium to support the transition to the stiffer balloon. A nitinolsuper-elastic mandrel can be provided to form a very tight initialradius that maintains its shape as the floppy lead-in catheter isadvanced but opens up as the stiffer balloon catheter is advanced.

As shown, the probe device 460 includes a finder tip 462, which could beshapeable or fixed and oriented outwardly to find an opening in a “wall”or infundibulum. The tip 462 could be made of a polymer or could be awire tip. The probe device 460 can further embody a mandrel 464 formedfrom shape memory, super elastic, spring steel or other semi-rigidmaterials. This helps keep angles very tight when solely selecting witha flexible catheter. Moreover, the probe device 460 may include aflexible finder catheter body 464, which acts like a guidewire to trackbehind the tip 462 and acts to confirm access to the sinus by advancingwithout resistance.

Referring now to FIG. 27, in one embodiment, a handle 470 for the probedevice 460 may include a thumb pusher 472 operatively connected to theballoon portion 474 so that manipulation of the pusher 472 advancesand/or retracts the balloon 474. The handle 470 may further include astabilization substructure 473 sized and shaped to receive figures of anoperator.

With reference now to FIGS. 28 a-28 c, in one embodiment of a method forusing a probe device 460, the probe device 460 may be placed in apre-deployment configuration (FIG. 28 a), with the mandrel 464 loadedwithin the flexible catheter body 466. During mid-deployment (FIG. 28b), the mandrel 464 is withdrawn proximally, but is left to extendbeyond the balloon portion 474. Next, the mandrel 464 is furtherwithdrawn proximal the balloon 474 (FIG. 28 c) to achieve completedeployment. The balloon 474 can then be expanded to create space oraccomplish desired tissue manipulation.

The above description has often focused on embodiments of devices,systems and methods for use in maxillary paranasal sinuses. In somecases, however, the above-described embodiments may be used inprocedures involving frontal, sphenoid and/or ethmoid sinuses. In somecases, these embodiments may be used as described in these othersinuses, while in other cases minor modifications may be made to thedevices, systems or methods to make them more amenable to use in thefrontal, sphenoid or ethmoid sinuses. In any event, the descriptionabove related to usage in the maxillary sinus should not be interpretedto limit the present invention to applications in only that sinus.

While the present invention has been described with reference to thespecific embodiments thereof, various changes may be made andequivalents may be substituted without departing from the true spiritand scope of the invention. In addition, many modifications may be madeto adapt a particular situation, material, composition of matter,process, process step or steps, to the objective, spirit and scope ofthe present invention. All such modifications are intended to be withinthe scope of the claims appended hereto.

What is claimed is:
 1. A device for locating and dilating a naturalostium of a maxillary sinus, the device comprising; (a) an elongateshaft assembly, comprising: (i) a substantially rigid straight proximalportion, (ii) a curved distal portion extending from a distal end of thestraight proximal portion, (iii) an atraumatic distal tip at the end ofthe curved distal portion, wherein the curved distal portion has a sizeand shape to allow passage of the distal portion into a nasal cavity toposition the atraumatic distal tip within or near a maxillary sinusostium, and (iv) an inflation lumen passing through at least part of theshaft assembly; and (b) at least one expandable dilator coupled with theshaft assembly, wherein the expandable dilator extends from the distalend of the straight proximal portion to a distal end of the curveddistal portion and encompasses the curved distal portion therebetween,wherein the expandable dilator is in fluid communication with theinflation lumen; wherein the atraumatic distal tip comprises aball-shaped tip for enhancing tactile feedback.
 2. The device as inclaim 1, wherein the expandable dilator comprises an inflatable balloon.3. The device as in claim 2, wherein at least a portion of the balloonis disposed proximal to a curve in the distal portion of the shaftassembly.
 4. The device as in claim 3, wherein the balloon extends fromproximal to the curve to distal to the curve along the shaft assembly.5. The device as in claim 2, wherein the dilator comprises two balloons,one disposed proximal to a curve of the distal portion of the shaftassembly and another disposed distal to the curve.
 6. The device as inclaim 2, wherein the balloon expends asymmetrically outward away from aninner radius of curvature of the curved distal portion of the shaftassembly.
 7. The device as in claim 1, further comprising a handleincluding an actuator, wherein the dilator is advanceable andretractable along the shaft assembly using the actuator.
 8. A device forlocating and dilating a natural ostium of a maxillary sinus, the devicecomprising; (a) an elongate shaft assembly, comprising: (i) asubstantially rigid straight proximal portion, (ii) a curved distalportion extending from a distal end of the straight proximal portion,(iii) an atraumatic distal tip at the end of the curved distal portion,wherein the curved distal portion has a size and shape to allow passageof the distal portion into a nasal cavity to position the distal tipwithin or near a dilation site in the nasal cavity, and (iv) aninflation lumen passing through at least part of the shaft assembly; and(b) at least one expandable dilator coupled with the shaft assembly,wherein the expandable dilator extends from the distal end of thestraight proximal portion and encompasses the curved distal portion,wherein the expandable dilator is in fluid communication with theinflation lumen; wherein the atraumatic distal tip comprises aball-shaped tip for enhancing tactile feedback.
 9. The device as inclaim 8, wherein the expandable dilator extends about the distal tip.10. A device for locating and dilating a natural ostium of a maxillarysinus, the device comprising; (a) an elongate shaft assembly,comprising: (i) a substantially rigid straight proximal portion, (ii) acurved distal portion, wherein the curved distal portion has a size andshape to allow passage of the distal portion into a nasal cavity, and anatraumatic distal tip at the end of the curved distal portion; (iii) aninflation lumen passing through at least part of the shaft assembly; and(b) at least one expandable dilator coupled with the shaft assembly,wherein a portion of the expandable dilator is expandable, wherein theexpandable dilator encompasses at least part of the curved distalportion and a portion of the straight proximal portion, wherein theexpandable dilator is in fluid communication with the inflation lumen;wherein the atraumatic distal tip comprises a ball-shaped tip forenhancing tactile feedback.
 11. The device as in claim 10, wherein theexpandable portion of the expandable dilator extends about the curveddistal portion of the shaft assembly.